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510(k) K132859

INTEGRA FACET FIXATION SYSTEM by Seaspine, Inc. — Product Code MRW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2013
Date Received
September 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Facet Screw Spinal Device
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Seaspine, Inc.

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  • K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
  • K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM (September 4, 2013)
  • K130830 — INTEGRA LAMINOPLASTY SYSTEM (May 9, 2013)
  • K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (December 12, 2012)
  • K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (January 25, 2012)
  • K111671 — SEASPINE MONOPOLAR PROBE SYSYEM (December 28, 2011)
  • K102026 — SEASPINE SPACER SYSTEM (May 12, 2011)

Other clearances for product code MRW

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  • K252153 — FFX Facet Fixation System (October 16, 2025)
  • K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
  • K250920 — Arthrex Spine Compression FT Screw (May 22, 2025)
  • K242527 — The Karma® Fixation System (May 21, 2025)
  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K243265 — Ion 3D (December 4, 2024)
  • K242650 — zLOCK Lumbar Facet Fixation System (September 20, 2024)